Environmental
Monitoring:
The Why, Where, What, and
How?
October
20, 2009 WEBINAR
NOON - 1:30 pm EDT
The FDA expects pharmaceutical
manufacturers to be in control of the environmental
conditions within the manufacturing facility. Controlling
the environmental condition is not only a regulatory
requirement but also part of protecting and producing a
quality product. This presentation will define what is
meant by environment, what conditions are required and how
such conditions maybe dictated by the type of product
being processed. The
presentation will then proceed to discuss how to obtain
the desired environmental conditions, manage the
conditions within the space, and what is required to
ensure that the environmental conditions remain in a state
of control. We will define standard environmental
conditions to be maintained in manufacturing space based
on published standards and compendial documents. A
hypothetical biotech manufacturing facility will be used
as an example to show the use of various conditions as
they apply to various activities within the processing of
a Biotech product. Finally the presentation will describe various
methods to monitor such conditions and where to monitor
within the space. The frequency of the monitoring will be
reviewed based on the criticality of the activity being
performed in the space. We will emphasize how to collect
the data and what to do with the data once collected.
Trending, identifying alert and action limits will be
defined and possible preventive and corrective actions
will be reviewed. Through
out the presentation we will review actual FDA 483
observation as they relate to environmental monitoring to
emphasize the issues of most concern to the regulators. We
will allow some time for Q&A at the conclusion of the
presentation. By
attending you will learn:
- What are the regulatory
requirements
- Where is the environment
- How to control the environment
- What are the basic methods to monitor
the environment
- Where to monitor within the
space
- What are the variables you should
monitor and the frequency of monitoring
- How to look for to and identify
potential problems
Instructor: Gamal Amer, Ph.
D.
Dr. Amer is Principal at Premier
Compliance Services, Inc.; Management Consultants for
compliance and manufacturing operations performance in the
life sciences industry. He holds a Ph. D. in Chemical
Engineering and has over 30 years of experience in the
Pharmaceutical and related industries. He has held
positions of increased responsibility with leading
pharmaceutical, consumer product and engineering
consulting firms over the years. His experience includes
comprehensive process design in bulk pharmaceutical
manufacturing, biotechnology manufacturing, pharmaceutical
solid dosage manufacturing and containment of potent and
radioactive therapeutics. He is also experienced with
facility development for therapeutic products operations.
Dr. Amer is a recognized expert in GMP compliance and
validation. He has consulted for many of the leading
pharmaceutical, biotechnology and medical device
manufacturers. He has lectured extensively in the US,
Europe, Asia and the Middle East, taught many courses, and
authored many papers which were published in peer reviewed
publication. He is a member of ISPE, PDA, ACS and
AIChE.
FEE: $345 for one person, $299 for second person,
$250 for third person.
Call for
special discounts to register more than 3 participants
from your company.
610-399-4897
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